SeaCare's Care Coordination for Diabetes Management in a Primary Care Office

This study has been terminated.
(insufficient recruitment of control and study patients)
Sponsor:
Collaborator:
New Hampshire Charitable Foundation
Information provided by:
SeaCare Health Services
ClinicalTrials.gov Identifier:
NCT00965510
First received: August 24, 2009
Last updated: September 29, 2011
Last verified: September 2010
  Purpose

The purpose of this study is to determine whether it is possible to improve health outcomes for patients with Type II diabetes, a community-based health care agency will offer care coordination to half of a study group in a family practice office. The intervention will include assessing patients' status using two instruments:

a depression screen (the PHQ9) and a motivation to change scale (the Patient Activation Measure, PAM). A masters-level social worker will counsel patients in the intervention group. Changes in patients' health status, PHQ9 scores and PAM scores over one year will be measured. Outcomes will be compared between the study group and the group without intervention.


Condition Intervention
Type 2 Diabetes
Behavioral: care coordination

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improved Management of Type II Diabetes in a Primary Care Office With Targeted Case Management

Resource links provided by NLM:


Further study details as provided by SeaCare Health Services:

Primary Outcome Measures:
  • Scores on PHQ9, PAM and health indicators [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Satisfaction with care coordination model. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Care Coordination
Patients receive care coordination to improve their diabetes.
Behavioral: care coordination
patients receive care coordination to improve their type II diabetes
No Intervention: control
patients with type II diabetes receive usual health care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes type II

Exclusion Criteria:

  • Non-English speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965510

Locations
United States, New Hampshire
Exeter Family Care
Exeter, New Hampshire, United States, 03833
Sponsors and Collaborators
SeaCare Health Services
New Hampshire Charitable Foundation
Investigators
Principal Investigator: Gwendolyn Gladstone, MD SeaCare Health Services
  More Information

No publications provided

Responsible Party: Gwendolyn Gladstone, MD, SeaCare Health Services
ClinicalTrials.gov Identifier: NCT00965510     History of Changes
Other Study ID Numbers: 9118277Downing306
Study First Received: August 24, 2009
Last Updated: September 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by SeaCare Health Services:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014